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Actemra – Liver Failure Risks

Actemra, a medication used for the treatment of RA, has been linked to life-threatening side effects including liver failure, cardiovascular events and GI perforation. On May 21, 2019, Canada’s health agency Health Canada issued a “Dear Doctor” letter which warned health care providers of a link between use of Actemra and an increase risk for drug-induced liver injury.

Actemra (tolizumab)

Actemra, a medication used for the treatment of RA, has been linked to life-threatening side effects including liver failure, cardiovascular events and GI perforation.

Genentech, manufacturer of Actemra, may be facing hundreds of lawsuits due to serious complications caused by the medication. People who have suffered liver failure, heart attack, stroke, lung failure or intestinal perforation or loved ones of those who have died after taking Actemra may be eligible for compensation.

Canadian health authority, Health Canada has issued a safety alert regarding a potential link between Actemra and liver failure. Multiple reports have been received by the U.S. Food and Drug Administration along with Canadian health agencies. No information regarding liver injury or liver failure has been included on prescribing information and the FDA has not commented.

In addition, the STAT News investigative group has identified 1,128 deaths that may be associated with the use of Actemra and has called for new warnings to be added to the labeling of the popular arthritis medication. The group found thousands of serious adverse event reports which included increased numbers of strokes, heart attacks, interstitial lung disease cases and GI perforations associated with Actemra use, some of which were fatal.

Genentech, manufacturer of Actemra, may be facing hundreds of lawsuits due to serious complications caused by the medication. People who have suffered liver failure, heart attack, stroke, lung failure or intestinal perforation or loved ones of those who have died after taking Actemra may be eligible for compensation.

About Actemra

Actemra, the brand name of tocilizumab, is a “monoclonal antibody” type drug which is given by IV infusion or subcutaneous (SC) injection. It is approved to treat autoimmune diseases including Rheumatoid Arthritis (RA), Systemic Juvenile Idiopathic Arthritis (SJIA), Polyarticular Juvenile Idiopathic Arthritis (PJIA) and for the rare disease, Giant Cell Arteritis (GCA) which affects blood vessels in the head and neck.

Autoimmune disorders occur when the immune system begins to identify the body’s own tissues as “foreign” and mobilizes to attack and destroy those tissues. Rheumatoid arthritis and other arthritic autoimmune disorders can result in joint inflammation, swelling, pain, and disability due to the destruction of joint tissue. Medications used to treat autoimmune disorders work by fighting inflammation or by blocking immune activity through a variety of means.

Actemra is an autoimmune medication which suppresses immune activation by blocking one of the chemical messengers, interleukin-6 (IL-6). It is manufactured by Genentech, a subsidiary of the pharmaceutical giant, Roche and produces an estimated $1.7 billion in annual revenue.

Lack of Safety Warnings

Most biologic immune-suppressing medications that are used for autoimmune disorders such as RA include a number of warnings about serious side effects. Medications such as Humira, Remicade, and Enbrel are known as TNF-alpha inhibitors and they, along with Actemra, include black-box warnings about a high risk of infections including tuberculosis, opportunistic infections, and invasive fungal infections.

Humira and other TNF-alpha medications also include warnings about serious effects on the heart, lungs and GI tract which Actemra does not carry. Because Actemra was intended to be an improvement over medications like Humira, the lack of certain safety warnings may falsely give the impression that Actemra is safer. A recent investigation by STAT News seems to indicate otherwise and may show that Actemra labeling should include warnings of heart, vascular and lung risks.

Both the Health Canada announcement and the report, published by STAT News, show that prescription labeling may not include enough information regarding safety issued.

Health Canada Warns of Liver Failure

On May 21, 2019, Canada’s health agency Health Canada issued a “Dear Doctor” letter which warned health care providers of a link between use of Actemra and an increase risk for drug-induced liver injury. In some cases, Actemra patients developed acute liver failure which was only treatable by liver transplant and may have resulted in numerous deaths.

Heath care providers are instructed to:

  • Perform pre-medication liver function and enzyme testing
    • Withhold beginning Actemra treatment in patients whose enzymes are 3 times that of the normal limit
    • Use only with caution in those whose enzymes are 1.5 times normal
  • Retest patients on regular basis
    • Every 4 to 8 weeks for adults
    • Every 2 to 4 weeks for children
  • Discontinue Actemra for patients whose levels reach 5 times normal limit
  • Instruct patients to contact provider immediately if liver failure symptoms occur such as:
    • Nausea and vomiting
    • Loss of appetited
    • Excessive fatigue
    • Itchy skin
    • Jaundice
    • Dark urine or pale feces
    • Abdominal swelling or pain

Neither the U.S. Food and Drug Administration (FDA), nor Actemra’s manufacturer Genentech, have not issued similar warnings. Though Actemra prescribing information contains instructions to monitor liver function, no warnings are included, and none have been added to labelling

STAT News Report Links Actemra to Numerous Deaths

STAT News published reporting shows that researchers examined thousands of FDA adverse drug reaction reports and found a much higher-than-expected number of deaths and other serious events. The group identified thousands of cases of heart attack, stroke, interstitial lung disease, gastrointestinal perforation and other serious adverse events which included 1,128 deaths in patients taking Actemra.

Analysis of the statistics showed that the risks of taking Actemra were as high, or even higher than other medications.

The most important findings appeared to be:

  • Actemra patients were 1.5 times more likely to have a heart attack or stroke as patients taking Enbrel
  • Actemra patients were more like to develop interstitial lung disease than those taking Remicade and just as likely as those taking Humira

The investigative group noted that the FDA has not certified a direct link for the deaths and no safety warnings have been issued. Some industry experts have stated that the current safety reporting system may be at fault, making it harder to identify and establish a cause. Recent years have seen drug approval pathways become easier but this means that some drugs may be approved without adequate safety information, particularly long-term safety data.

Unlike other countries, the U.S. system does not have a well-organized post-approval safety monitoring program and reporting of adverse events is considered “voluntary”. In addition, the FDA’s database is not well-organized and may make it difficult to tabulate data and identify trends. Many reports are filed using non-standard language, inaccurate descriptions and may be missing important information.

Based on the investigative conclusion, STAT News is calling for the addition of warnings to Actemra prescribing information. Genentech/Roche, Actemra’s manufacturer has stated that they will review the data but no action has been taken by the FDA or the company.

Actemra Side Effects

Like all medications, Actemra has a number of side effects. Some side effects are mild to moderate and will go away with time but others can be serious or life-threatening.

Common side effects identified for Actemra may include:

  • A headache
  • Increased blood pressure
  • Upper respiratory infection
  • Injection site reaction
  • Laboratory test changes
    • Increased liver enzymes
    • Lowered white blood cell counts
    • Lowered platelet count
    • Increased blood cholesterol

Blood laboratory testing should be performed regularly. Drug dosing may require adjustments, treatment delay or discontinuation due to abnormal laboratory results.

Serious side effects of Actemra listed on prescribing information include:

Infection Risk

Actemra works by suppressing the immune system and lowers the ability to fight an infection. This may increase the risk for:

  • Common illnesses like colds and flu
  • Less common infections which are difficult to treat such as:
    • Invasive fungal infections like aspergillus, candidiasis, Pneumocystis
    • Opportunistic infection from bacteria, virus or parasitic organism
    • Recurring infections which require longer, more aggressive treatment
    • Activation of latent tuberculosis
    • Activation of latent viral infection like Herpes/Varicella-Zoster or Hepatitis B

Patients who are taking Actemra should be monitored and asked to report any signs of infection. Symptoms of infection may require delay or discontinuation of future Actemra doses.

Severe Allergy

Actemra has been shown to cause serious allergic reactions in some patients, including some cases of anaphylaxis and death.

Symptoms of allergy warrant emergency treatment and may include:

  • Rash or hives
  • Skin flushing
  • Swelling of face, mouth or throat
  • Chest pain
  • Severe nausea, vomiting or abdominal pain

Gastrointestinal Tear or Perforation

Actemra may increase the risk for gastrointestinal perforation. GI tears may cause excessive bleeding and leakage of intestinal contents into the abdominal cavity.

Symptoms of GI perforation should be treated as a medical emergency and may include:

  • Stomach or abdominal pain
  • Abdominal swelling
  • Excessive fatigue, faintness
  • Fever

Taking medications that irritate the GI system may increase the risk of GI perforation. GI-irritant medications may include other drugs taken for RA such NSAIDs like ibuprofen, diclofenac, and naproxen, corticosteroids like prednisone, and immunosuppressives like methotrexate.

Actemra Lawsuits

Thousands of people may have already been harmed after taking Actemra and many may still be at risk of serious side effects including heart attack, stroke, lung disease or even death. Other patients have experienced drug-induced liver injury or acute liver failure and required liver transplant. Some Actemra lawsuits have already been filed and more may be expected.

Past medical injury plaintiffs have received compensation for medical costs, lost wages, pain, and suffering or wrongful death. In some cases, drug manufacturers have also been required to pay punitive damages if it was proven that a drug was known to be defective but the company failed to warn about the dangers.

Patients or family members of those who have been harmed or died after taking Actemra may be eligible for compensation for their injuries or loss through an Actemra lawsuit.

Each case is unique and must be evaluated separately by a legal expert.

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